This invention relates to the field hemostasis devices; that is, medical instruments designed to stanch the flow of blood from a ruptured or punctured blood vessel. More specifically, in one aspect, the present invention relates to a percutaneous hemostasis device, i.e., a device that can reach through the skin and subcutaneous tissue to promote hemostasis in a perforated or punctured bodily lumen, such as a blood vessel. In another aspect, the present invention relates to the method of using such a device to promote hemostasis at a perforation or puncture site in a subcutaneous bodily lumen, particularly a blood vessel.
A growing number of therapeutic and diagnostic medical procedures involve the percutaneous introduction of instrumentation into a vein or artery. For example, percutaneous transluminal coronary angioplasty (PTCA), most often involving the femoral artery, is performed hundreds of thousands of times annually, while other vessel-piercing procedures (e.g., percutaneous coronary angiography and atherectomy) number more than two million per year.
In each event, the closing and subsequent healing of the resultant vascular puncture is critical to the successful completion of the procedure. Traditionally, the application of external pressure to the skin entry site has been employed to stem bleeding from the wound until clotting and tissue rebuilding have sealed the perforation. (See, for example, U.S. Pat. No. 5,342,388--Toller, which discloses an external pressure application device for effecting hemostasis in a femoral artery puncture.) In some situations, this pressure must be maintained for up to an hour or more, during which the patient is immobilized, often with sandbags or the like. With externally-applied manual pressure, both patient comfort and practitioner efficiency are impaired. Additionally, a risk of hematoma exists, since bleeding from the vessel may continue until sufficient clotting effects hemostasis. Also, external pressure application devices may be unsuitable for patients with substantial amounts of subcutaneous adipose tissue, since the skin surface may be a considerable distance from the vascular puncture site, thereby rendering skin compression inaccurate and thus less effective.
Consequently, devices have been developed for promoting hemostasis directly at the site of the vascular perforation. For example, there are devices that deploy intraluminal plugs within the vessel to close the puncture site, as disclosed in the following U.S. Pat. Nos.: 4,852,568--Kensey; 4,890,612--Kensey; 5,021,059--Kensey et al.; and 5,061,274--Kensey. Another approach is to deliver a tissue adhesive or clotting agent to the perforation site, as disclosed in the following U.S. Pat. Nos.: 5,221,259--Weldon et al.; 5,383,899--Hamrnmerslag; 5,419,765--Weldon et al.; and 5,486,195--Myers et al. This method may entail some risk of disadvantageously introducing some of the adhesive or clotting agent into the bloodstream. Still another approach is the application of pressure directly to the perforation site, as exemplified by PCT International Publication Number WO 95/32671; U.S. Pat. No. 4,619,261--Guerrieo; and U.S. Pat. No. 4,929,246--Sinofsky, the last-named disclosing the simultaneous application of direct pressure to the perforated vessel and the direction of laser energy through an optical fiber to cauterize the wound. Yet another approach is disclosed in U.S. Pat. No. 5,275,616--Fowler, wherein a cylindrical plug is inserted along the shaft of a catheter segment extending from the skin surface to the blood vessel. The catheter is then removed so that the plug can expand as fluid is drawn into the plug from the vessel and the surrounding tissue. Unless pressure is applied, however, bleeding may occur around the plug into the subcutaneous tissue. A similar concept is disclosed in U.S. Pat. No. 5,391,183--Janzen et al., which discloses a variety of plug delivery devices, including threaded plug pushers and multilegged channels, that install a plug that may be resorbable.
Many of the above-noted devices rely, to varying degrees, on tactile sensation alone to indicate to the surgeon the proper placement of the puncture closing instrumentation, and they may also require upstream clamping of the blood vessel to reduce intraluminal pressure to approximately atmospheric pressure at the puncture site.
Another type of percutaneous vascular hemostasis device is exemplified in U.S. Pat. Nos. 5,417,699 and 5,527,322, both to Klein et al. This type of device comprises a mechanism for delivering a suture percutaneously to a vascular suturing site, and then tying the suture in situ. While such devices, if properly employed, are capable of very effectively stemming blood flow, they may require a relatively high degree of dexterity to be operated properly. Furthermore, they tend to be somewhat complex and expensive to manufacture, and thus are not practically employed as single use, disposable products. Consequently, sterilization is required between uses to reduce the risk of infection, thereby increasing their cost and inconvenience.
Accordingly, there has been a long-felt need for an effective percutaneous vascular hemostasis device that is relatively simple and inexpensive to manufacture and easy to use, that is adapted for use as disposable device, and that does not require the introduction of a foreign sutbstance--such as a plug, tissue adhesive, or clotting agent--into the bloodstream.